Powered Communication System For Emergency Use

QNZ · Not classified · Unknown

Classification

FDA Product Code: QNZ
Device class: Not classified
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 8
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

Definition

Powered environmental control system to support remote nurse call events, including those originating from ventilators, by trained health care providers from outside an isolation unit to avoid unnecessary exposures during the declared public health emergency.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown